Ex Parte SHALON et al

Patent Trial and Appeal Board

Feb 15, 2019

14827207 (P.T.A.B. Feb. 15, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/827,207 08/14/2015
66854 7590
SHAY GLENN LLP
2755 CAMPUS DRIVE
SUITE 210
SAN MATEO, CA 94403
02/20/2019
FIRST NAMED INVENTOR
Tadmor SHALON
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
12993-700.300 6529
EXAMINER
CRUZ, KATHRIEN ANN
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
02/20/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
info@shayglenn.com
shayglenn_pair@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TADMOR SHALON and BRADFORD RABIN
Appeal2018-002408
Application 14/827 ,207
Technology Center 1600
Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a
method of promoting weight loss. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Livelight LLC (see App.
Br. 2).
2 We have considered and herein refer to the Specification of Aug. 14, 2015
("Spec."); Non-Final Office Action of Apr. 5, 2017 ("Non-Final Act.");
Appeal Brief of June 20, 2017 ("App. Br."); Examiner's Answer of Nov. 2,
2017 ("Ans."); and Reply Brief of Jan. 2, 2018 ("Reply Br.").
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Application 14/827 ,207
Statement of the Case
Background
"Various drugs and drug administration, doses, and dosing schedules
have been used to treat obesity, but all have proven inadequate because they
quickly lose their anorexiant effect due to patient buildup of tolerance and
because they tend to have significant adverse effects" (Spec. ,r 3).
Phentermine "has been used as oral monotherapy for obesity ... [ and] acts
on the cerebral appetite center to reduce appetite" (Spec. ,r 4). However,
phentermine "quickly loses effect" when given continuously and "is
associated with important adverse effects, including insomnia and
nervousness, resulting in reduced efficacy due to patient noncompliance"
(Spec. ,r,r 4--5). "[P]revious studies looked into intermittent therapy by
alternating phentermine and placebo" but "have reported significant patient
dropout rates in a typical 8-12 weeks phentermine clinical trial" (Spec. ,r,r 5,
7). The invention provides "a phentermine weight loss treatment regimen
which traverses the loss-of-effect and side effect limitations typically
associated with continuous phentermine therapy" (Spec. ,r 10).
The Claims
Claims 9, 10, 12-15, 21, and 22 are on appeal. Independent claim 9 is
representative and reads as follows:
9. A method of promoting weight loss in a patient, comprising:
administering daily doses from a first collection of dose units to
a patient according to a dose regimen, the first collection of
dose units comprising a first dose unit comprising an inert
excipient and an amount of phentermine in a range of 5-35
mg and a subsequent dose unit comprising an inert excipient
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Application 14/827 ,207
and 0-2 mg of phentermine, wherein all of the dose units of
the first collection of dose units appear identical;
obtaining a weight of the patient, a hunger level of the patient,
or level of side effects caused within the patient by taking
the first collection of dose units, as reported by the patient;
after administration of the first collection of dose units, based
upon the weight, hunger level, or level of side effects,
adjusting the dose regimen to set an adjusted dose regimen
having an adjusted first dose unit comprising an inert
excipient and an adjusted amount of phentermine in a range
of 5-35 mg and differing from the amount of phentermine in
the first dose unit of the first collection and a subsequent
dose unit comprising an inert excipient and 0-2 mg of
phentermine; and
administering daily doses from a second collection of dose units
to the patient according to the adjusted dose regimen for a
total of twelve weeks after commencing administering daily
doses from the first collection of dose units.
The Re} ection
The Examiner rejected claims 9, 10, 12-15, 21, and 22 under 35
U.S.C. § I03(a) as obvious over Kim3 and McKinney4 (Non-Final Act. 5-
12).
The Examiner finds that Kim teaches "12 weeks administration of
phentermine-HCl 37.5 mg had induced clinically significant weight
reduction" (Non-Final Act. 6). The Examiner finds that Kim teaches "body
3 Kim et al., Effects on Weight Reduction and Safety of Short-Term
Phentermine Administration in Korean Obese People, 47 YONSEI MED. J.
614---625 (2006).
4 McKinney et al., US 2008/0110792 Al, published May 15, 2008.
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Application 14/827 ,207
weight, waist circumference, and blood pressure were measured at the outset
and at every subsequent visit" (id.). The Examiner acknowledges that "Kim
does not disclose the plurality of doses." (id. at 7).
The Examiner finds that McKinney teaches methods for weight loss
"using a unit dosage package that includes a first unit dosage that has a first
drug and a second drug, a second unit dosage that has the first drug and the
second drug, where the second unit dosage includes a different amount of
the second drug than the first unit dosage" (Non-Final Act. 7). The
Examiner finds that McKinney teaches "one or more of [the] drugs
comprises phentermine and one or more of the drugs comprise topiramate"
(Non-Final Act. 8). The Examiner finds that McKinney teaches that "the
dosages are provided at least once ... a day for a set period" which can
range from 1-30 consecutive days, 1-30 consecutive weeks, or 1-30
consecutive months (Non-Final Act. 8-9). The Examiner finds McKinney
teaches that "the amount of drug in any pharmaceutical formulation
described herein includes amounts" in the range of 0.1--40 mg (Non-Final
Act. 9).
The Examiner determines "[i]t would have been obvious to one of
ordinary skills in the art to administer phentermine or any medication in a
plurality of dosing [sic] because it is well known in the art to administer [a]
plurality of dose units of the same or different medications as taught by
McKinney" (Non-Final Act. 11). The Examiner determines "it is obvious to
vary and/or optimize the amount of medication provided in the composition,
according to the guidance provided by both Kim and McKinney, to provide
a composition having the desired properties such as the desired (ratios,
concentrations, percentages, etc.)" (id.). As to Appellants' evidence of
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Application 14/827 ,207
unexpected results, the Examiner finds that "the dosing described in the
declaration overlap with ... the cited prior art" and "the declaration teaches
a subset however the instant claims recite 5-3 5 mg of phentermine, therefore
the instant claims are not commensurate in scope of the declaration" (Ans.
14).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that the combination of Kim and
McKinney renders the claims obvious?
Findings of Fact ("FF'')
1. Kim teaches "12 weeks administration of phentermine-
H Cl 37.5 mg[] induced clinical significantly weight reduction" where
"over 80% of subject of phentermine group lost 5% or more of initial
weight and more than half subjects lost 10% or more" (Kim 622).
2. Kim describes other studies, including Munro5 which
teaches "intermittent phentermine therapy ( administration of
phentermine and placebo every 4 weeks, alternatively) for 36
weeks ... resulted in significant weight reduction" (Kim 622).
3. Kim teaches "a randomized, double-blind, placebo-
controlled study with the initial screening period and the 14 weeks of
treatment period including 2-week single-blind placebo run-in period"
(Kim 616).
4. Kim teaches "subjects who had been permitted for the
study participation were randomized to treatment with phentermine
HCl 37.5 mg once daily or placebo at Baseline" (Kim 616).
5 Munro et al., Comparison of Continuous and Intermittent Anorectic
Therapy in Obesity, 1 BR. MED. J. 352-354 (1968).
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Application 14/827 ,207
5. Kim teaches "[a]fter [a] 2-week placebo run-in period, all
subjects were required to visit the hospital every 4 weeks" and
"[b Jody weight, waist circumference, and blood pressure were
measured at the outset and at every subsequent visit" (Kim 616).
6. McKinney teaches a "method[] for administering weight
loss medications" including
using a unit dosage package that includes a first unit dosage that
has a first drug and a second drug, a second unit dosage that has
the first drug and the second drug, where the second unit
dosage includes a different amount of the second drug than the
first unit dosage
(McKinney Abstract; claims 1, 31 ).
7. McKinney teaches the methods "involve altering the
dosage of one or more components of a multi-component formulation
during the course of administration" whereby "adverse side effects are
reduced, and patient compliance and comfort are increased, thereby
increasing the efficacy of the treatment regimen" (McKinney ,r 9).
8. McKinney teaches a dosage package in Figure 3A, where
"a specific day 302 and time 304 corresponds to a single unit dosage"
(McKinney ,r 52).
9. McKinney teaches the dosage package may include "a
series of unit dosages each dosage compris[ing] a static amount of a
first drug and varying dosages of a second drug" (McKinney ,r 52).
10. McKinney teaches that first drug may include topiramate
and the second drug may include phentermine (McKinney ,r 124,
claims 17, 38).
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Application 14/827 ,207
11. McKinney teaches that "the dosages are provided at least
once, twice or three times a day for a set period, which can be at least"
1-30 consecutive days, 1-30 consecutive weeks, or 1-30 consecutive
months (McKinney ,r 137).
12. McKinney teaches that "[t]he amount of drug in any
pharmaceutical formulation described herein includes amounts of at
least" 0.1--40 mg, including specifically 1, 2, 5, 7, 10, 15, 30, 35, and
40 mg (McKinney ,r 137).
Principles of Law
"In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed purpose of the
patentee controls. What matters is the objective reach of the claim. If the
claim extends to what is obvious, it is invalid under§ 103." KSR Int'! Co. v.
Teleflex Inc., 550 U.S. 398, 419 (2007).
Analysis
We adopt the Examiner's findings of fact and conclusion of law (see
Non Final Act. 5-12; FF 1-12) and agree that the combination of Kim and
McKinney renders the claims obvious. We address Appellants' arguments
below.
We begin with claim interpretation. Claim 9 recites "administering
daily doses from a first collection of dose units" "comprising a first dose unit
comprising ... an amount of phentermine in a range of 5-35 mg and a
subsequent dose unit comprising ... 0-2 mg phentermine." Although the
claim recites administering "according to a dose regimen," the claim does
not recite any specific sequence or timing of dosing, other than a
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Application 14/827 ,207
"subsequent," i.e., following, dose unit of 0-2 mg phentermine. Appellants
argue that "[ c ]laim 9 recites a weight loss promotion method in which
phentermine amounts vary dramatically from dose to dose in a very
particular way" (App. Br. 6). We do not find this persuasive because
Appellants are arguing limitations that are not present in the plain meaning
of the language of the claim. See Sjolund v. Musland, 847 F.2d 1573, 1581
(Fed. Cir. 1988) ("[W]hile it is true that claims are to be interpreted in light
of the specification and with a view to ascertaining the invention, it does not
follow that limitations from the specification may be read into the claims").
Claim 9 recites "a subsequent dose unit comprising an inert excipient
and 0-2 mg of phentermine" (App. Br. 9). Appellants argue although
"McKinney does mention the delivery of phentermine together with
topiramate to treat weight loss, McKinney does not mention any particular
dose regimen, certainly not a dose regimen in which a first dose unit has 5-
35 mg of phentermine and a subsequent dose unit has 0-2 mg of
phentermine" (App. Br. 5). However, the plain meaning of a dose unit
"comprising an inert excipient and 0-2 mg of phentermine" does not exclude
other active agents, such as topiramate. See Georgia-Pacific Corp. v. US.
Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999) (The transitional term
"comprising" is "inclusive or open-ended and does not exclude additional,
unrecited elements or method steps"). Giving claim 9 its broadest
reasonable interpretation that is consistent with the Specification (see Spec.
,r 51 "For example, other obesity drugs, such as a combination of
phentermine and torpiramate, could be used."), we determine that the
subsequent dose unit encompasses a composition containing an inert
excipient, no phentermine (see also claim 12), and topiramate, as taught by
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McKinney (FF 10). See In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000)
("[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification").
Appellants argue "[ w ]hile McKinney mentions generally that a second
dose can have a lower amount of one of the drugs, McKinney ... does not
suggest any reason or advantage for delivery a second dose lower than a first
dose" (App. Br. 5). The plain language of claim 9 does not require "the
second dose ... have a lower amount of one of the drugs" as argued; rather,
the claim recites "an adjusted first dose unit comprising an inert excipient
and an adjusted amount of phentermine ... differing from the amount of
phentermine in the first dose unit of the first collection." McKinney teaches
the identical configuration where "the second unit dosage includes a
different amount of the second drug than the first unit dosage" (FF 6).
After interpreting the claims, we address Appellants' arguments
against the Examiner's rejections. Appellants argue that the "Examiner did
not accurately identify differences between the claimed invention and the
prior art" (App. Br. 5). Appellants argue that
Differences between Kim and the claimed invention recited in
claim 9 include the steps of ( 1) administering to each patient
doses that differ in phentermine concentration such that a first
dose unit has 5-30 mg of phentermine and a subsequent dose
unit has 0-2 mg of phentermine; (2) adjusting the dose regimen
for that patient based on weight, hunger level, or level of side
effects reported by the patient; and (3) administering an
adjusted dose regimen having an adjusted amount of
phentermine that differs from the amount of phentermine
administered earlier but also has first dose unit with 5-30 mg of
phentermine and a subsequent dose unit with 0-2 mg of
phentermine
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Application 14/827 ,207
(id.). Appellants argue that the Examiner "does not explicitly identify any
differences between claim 9 and McKinney" and "[t]his failure to
completely and accurately identify the differences between claim 9 and the
prior art requires reversal" (id.).
We do not find this argument persuasive for at least two reasons.
First, Appellants attack the references individually, rather than addressing
the prior art combination as a whole. See In re Merck & Co., 800 F .2d 1091,
1097 (Fed. Cir. 1986). Second, the Examiner acknowledges the need to
optimize "the amount of medication provided" in the prior art combination
"to provide a composition having the desired properties such as the desired
(ratios, concentrations, percentages, etc.)" (Non-Final Act. 11). Therefore,
the Examiner identifies that the combined prior art does not teach adjusting
the specific amounts of medication in the first and second collection of dose
units, and instead relies on optimizing by routine experimentation (See Non-
Final Act. 11 ).
Appellants argue that the Examiner does not provide sufficient
rationale for modifying the prior art to address the differences in adjusting
the specific amounts of medication (App. Br. 6). We are not persuaded as
our obviousness analysis "can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ." KSR, 550 U.S.
at 418. McKinney specifically teaches altering the dosage to reduce adverse
side effects and improve patient compliance (FF 7), by administering a
second unit dosage having a different amount of drug than a first unit dosage
(FF 6). Kim specifically teaches a phentermine regimen that includes
measuring body weight at the outset of treatment and every subsequent visit
(four weeks) (FF 5). Taken together, the prior art teaches promoting weight
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loss by administering phentermine and non-phentermine dosage units and
adjusting the phentermine dose while monitoring patient weight. Therefore,
as stated by the Examiner, the prior art teaches the general conditions of the
claim, whereby "it is not inventive to discover the optimum or workable
ranges by routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA
1955).
Appellants argue "the Rabin Declaration demonstrates the
unobviousness of the claims" (App. Br. 7). In particular, the Appellants
argue the "unexpectedly positive results are a direct consequence of the
method recited by claim 9: administering a dose regimen using varying
amounts of phentermine from dose to dose and less phentermine overall"
(id.). We do not find this argument persuasive because "objective evidence
of nonobviousness must be commensurate in scope with the claims." In re
Lindner, 457 F.2d 506, 508 (CCPA 1972). As discussed in the claim
interpretation above, the rejected claims do not recite varying amounts of
phentermine from "dose to dose" or administering "less phentermine
overall." Accordingly, the evidence of unexpected results are not
commensurate with the scope of the claims.
Appellants argue claim 12 separately, stating "nothing in either Kim
or McKinney discloses or suggests a weight loss dosing regimen in which a
first dose has an amount of phentermine in a range of 5-35 mg and a
subsequent dose has only an inert excipient" (App. Br. 8). However,
because claim 12 recites the open-ended "comprising" the dose unit does not
exclude additional components. Therefore, the dose unit is taught by the
topiramate dose unit of McKinney, which contains no phentermine.
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Conclusion of Law
A preponderance of the evidence of record support the Examiner's
conclusion that the prior art renders claims 9 and 12 obvious.
SUMMARY
In summary, we affirm the rejection of claims 9 and 12 under 35
U.S.C. § 103(a) as being obvious over Kim and McKinney. Claims 10, 13-
15, 21, and 22 fall with claim 9.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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